Seven Oncology Set-Backs in 2017

Contributors : Andrew Merron: Ph.D., Executive Director, Oncology and Biosimilars, Biopharma Insights

Publish date: 05 Jan, 2018

While major advances in oncology took place in 2017, there were also some notable set-backs, including clinical disappointments within the immune checkpoint inhibitor class.

1. Despite some earlier encouraging Phase II data, in April 2017 BMS revealed that Opdivo failed to significantly improve overall survival compared with Avastin (the standard of care) in the Phase III CheckMate-143 study which was evaluating second-line glioblastoma multiforme patients. Other trials evaluating Opdivo in glioblastoma multiforme continue.

2. In May 2017, data from the pivotal Phase III IMvigor-211 trial revealed that Tecentriq failed to significantly improve overall survival compared with chemotherapy for advanced or metastatic urothelial carcinoma patients with disease progression during or after platinum-based chemotherapy. The trial was intended to support continued approval (accelerated approval was granted in May 2016).

3. In July 2017, AstraZeneca announced that Imfinzi plus tremelimumab failed to meet its primary endpoint of progression-free survival for first-line PD-L1 positive NSCLC patients (in the Phase III MYSTIC trial). Although this is a significant blow to the development of the combination in the first-line setting, some interviewed physicians emphasize that the overall survival endpoint could still be reached.

4. In July 2017, Keytruda failed to meet primary endpoint of overall survival compared with current standards of care for previously treated recurrent or metastatic squamous cell carcinoma of the head and neck patients (in the Phase III KEYNOTE-040 trial). While Keytruda did not reach its primary end point, it was superior to investigator’s choice in terms of toxicity, an important consideration in treatment decisions for these poor-prognosis patients. Furthermore, subsequent treatment with an immunotherapy in the standard-of-care arm may have confounded overall survival analysis. There was also a trends towards an overall survival benefit in patients with PD-L1 combined positive score ≥ 1%, especially those with combined positive score ≥ 50%.

5. Developers of immune checkpoint inhibitors hit a stumbling block in multiple myeloma in 2017. As a result of a number of unexpected deaths in the combination experimental arms of Keytruda’s KEYNOTE trials, clinical holds have been placed on several studies of Keytruda and Opdivo (including all late-phase studies). The FDA considers the potential risks of adding PD-1 inhibitors to already established multiple myeloma treatments to outweigh the potential benefits. The future of PD-1/PD-L1 targeting agents (particularly in combination with other therapies) for multiple myeloma remains uncertain until further light is shed on the safety of such regimens.

6. Late in November, data from the pivotal Phase III JAVELIN trial revealed that Bavencio failed to demonstrates significant improvement in overall survival compared with chemotherapy for third-line unresectable, recurrent, or metastatic gastric cancer patients. Currently. Keytruda is the only immune checkpoint to be FDA approved for gastric cancer (approval was granted in September 2017).

7. In December 2017, Keytruda failed to significantly improve overall survival compared with paclitaxel for PD-L1 positive second-line gastric and gastroesophageal junction cancer patients (in the Phase III KEYNOTE-061 trial). The co-primary endpoint of progression-free survival was also not significantly improved. Nevertheless, the Phase III KEYNOTE-062 trial is ongoing and evaluating Keytruda in the first-line setting among PD-L1 positive patients.

Despite these clinical setbacks, 2017 was a particularly busy and productive year in oncology. Not only here at Decision Resources Group (the oncology team launched two new data and insight solutions) but also within the oncology pharmaceutical and regulatory sectors.

The pace of clinical development, the number of revolutionary new treatments approved, and the sheer volume of clinical data has been overwhelming. While significant progress in innovation was demonstrated in 2017, we also witnessed approvals of several ‘me-too’ and same-in-class drugs in oncology.

Want to learn more? Read our list of the top 5 trends that we think made 2017 a year to remember for oncology.



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